Overview

2-Year Therapy With Teriparatide vs 1-yr Therapy Followed by 1-Year of Raloxifene or Calcium/Vit D in Severe Postmenopausal Osteoporosis

Status:
Completed
Trial end date:
2005-11-01
Target enrollment:
0
Participant gender:
Female
Summary
The primary purpose of the study is to compare 3 different osteoporosis therapies following one year of teriparatide.In the first year,all eligible patients received open-label teriparatide 20 micrograms/day.After 1 year, patients are randomly assigned to one of 3 possible follow-up treatment regimens for the second 12 months: continuation of teriparatide, switch to raloxifene, or no pharmacological treatment(other than the calcium and vitamin D supplements that everyone receives). Patients are stratified into 3 subsets: (a) patients who have never received any anti-osteoporosis treatment before; (b) patients who received prior antiresorptive treatment successfully; (c) patients who failed to respond adequately to prior antiresorptive drugs (such as bisphosphonates or raloxifene) in the past. These latter patients are not randomized at month 12 but will continue treatment with teriparatide 20 micrograms/day throughout the second year.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Treatments:
Raloxifene Hydrochloride
Teriparatide
Criteria
Inclusion Criteria:

- Ambulatory women greater or equal to 55 years, at least 2 years postmenopausal.

- Lumbar spine or total hip or femoral neck bone mineral density measurement must be at
least 2.5 standard deviations (SD) below the average bone mass for young women
(T-score -2.5 or less).

- Presence of at least one known and documented preexisting clinical fragility fracture,
in the past 3 years.

Patients may be included in substudy 2 if they meet any one of the following additional
criteria - Patients who have sustained at least one new fragility fracture (vertebral or
nonvertebral), despite prescription of antiresorptive therapy* during the 12 months prior
to the last new fracture or patients who, after a minimum of two years after initiating
antiresorptive therapy*, either have a lumbar spine, femoral neck, or total hip BMD of at
least - 3SD below the average bone mass for young women (T-score -3 or less), or who show a
decrease of at least 3.5% in BMD at any one of these sites.

*Antiresorptive therapy includes all bisphosphonates, raloxifene, ERT/HRT, calcitonin, and
vitamin D metabolites.

Exclusion Criteria:

For substudy 1 patients only:

- current or history of vaginal bleeding or spotting of unknown cause in the 1 year
prior to study start

- currently suspected or history of venous thrombotic events (VTE), including lower
extremity thrombosis, and other major venous thromboses, or high risk of developing
VTE as assessment by the investigator.

Treatment with

- Vitamin D >50,000 IU/week or with any dose of calcitriol or vitamin D analogs or
agonists in the 6 months prior to visit 2

- Fluorides in the 12 months prior to visit 2.

- Systemic corticosteroids (other than for replacement therapy) in the 1 month prior to
visit 2.(Ophthalmic, otic topical, orally inhaled, nasally inhaled, or intra-articular
corticosteroid therapy may be used without these restrictions.)